Efficacy Study of Paclitaxel Versus Irinotecan in Patients With Recurrent or Metastatic Gastric Cancer Who Progress Following First-line Therapy

A Randomized, Multicenter Phase III Study to Assess the Efficacy of Paclitaxel Versus Irinotecan in Patients With Recurrent or Metastatic Gastric Cancer Who Progress Following First-line Therapy

The primary objectives of this study is to compare the efficacy of paclitaxel monotherapy with irinotecan monotherapy as defined by progression-free survival (PFS), in all patients with recurrent and metastatic gastric cancer who progress following first line therapy.

Inclusion Criteria:

• Histologically confirmed gastric adenocarcinoma in tissue/cell
• Recurrent or metastatic gastric cancer that has progressed following first- line therapy
• Patients must be ≥18 years of age.
• ECOG performance status ≤ 2
• At least one lesion (measurable or non-measurable but evaluable) according to RECIST criteria
• Normal organ and bone marrow function measured within 2 weeks prior to administration of study treatment as defined below: Haemoglobin ≥ 9.0 g/dL White blood cells (WBC) ≥ 3000/µL Absolute neutrophil count (ANC) ≥ 1500/µL Platelet count ≥ 100 x 103/µL Total bilirubin ≤ 1.5 x upper normal limit (UNL) Creatinine clearance ≥ 60 ml/min or Serum creatinine ≤ 1.5 x UNL AST (SGOT)/ALT (SGPT) ≤ 2.5 x UNL unless liver metastases are present in which case it must be ≤ 5x UNL
• Life expectancy ≥ 12 weeks.
• Written informed consent
• Provision of informed consent for genetic research (In case of optional genetic research)

Exclusion Criteria:

• More than one prior chemotherapy regimen for the treatment of gastric cancer in the metastatic or recurrent setting.
• Treatment with any investigational product during the last 14 days (or a longer period depending on the defined characteristics of the agents used).
• Any previous treatment with a taxane, including paclitaxel and docetaxel or irinotecan, in the metastatic or recurrent setting.
• Patients with second primary cancer, except: adequately treated non- melanoma skin cancer, curatively treated in-situ cancer of the cervix, or other solid tumors curatively treated with no evidence of disease for ≥5 years.
• Patients receiving any systemic chemotherapy, radiotherapy (except for palliative reasons), within 2 weeks from the last dose prior to study treatment (or a longer period depending on the defined characteristics of the agents used).
• Ongoing toxicities (>CTCAE grade 2) caused by previous cancer therapy.
• Clinically proven gastric outlet obstruction or CTCAE grade 3 or grade 4 upper GI bleeding
• Medically uncontrolled, clinically significant heart disease or infection
• Patients with symptomatic uncontrolled brain metastases.
• Major surgery within 2 weeks of starting study treatment and patients must have recovered from any effects of any major surgery.
• Women who have pregnancy potential or willing to pregnant. Pregnant and breastfeeding women.
• Others Poor medical risk due to a serious, uncontrolled medical disorder, non- malignant systemic disease or active, uncontrolled infection Any psychiatric disorder that prohibits obtaining informed consent and regular follow-up. Inappropriate patient for subjects of this study on investigator's judgment